Z-0756-2013Class II

BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75...

Name: Z-0756-2013 BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75...
Creator: Becton Dickinson & Company
Published: 2012-11-12
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2012-11-12 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL on 2012-11-12. FDA classified it as Class II and gives the reason as "BD is conducting a recall of the BD Vacutainer 2.7mL Plus Citrate Blood Collection Tube due to extended Partial Thromboplastin Time (aPTT) test results reported in two customer complaints". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0756-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-12
Posted: 2015-06-26
Terminated: 2013-09-06
Recalling firm: Becton Dickinson & Co
Product: BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: BD is conducting a recall of the BD Vacutainer 2.7mL Plus Citrate Blood Collection Tube due to extended Partial Thromboplastin Time (aPTT) test results reported in two customer complaints.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: BD sent "ATTENTION: PRODUCT RECALL" letters dated November 12, 2012 via UPS to distributors and customers instructing them to examine their inventory immediately and discontinue the shipment of the affected product. All customers were instructed to return all products from the lot affected, by following the instructions on the enclosed packing slip,and BD will send them replacement products at no charge. Contact the firm at 10201-847-4267 for assistance.
Quantity in commerce: 2,944,700 units
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Canada, India, Japan, Nepal, Malaysia, Singapore, Brazil, Costa Rica, and Virgin Islands.
Product codes and lots: Lot No. 2180434; Expiration Date: April 2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0756-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0756-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-06	2013-01-31

Product code JKA

K013971Class IIBd Vacutainer Safety Coagulation TubeBecton, Dickinson & CO / cleared 2002-02-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)